Complementary and Integrative Therapy for Diabetic Neuropathy

Effectiveness of a Complementary and Integrative Therapy in Diabetic Neuropathy Patients.

Sponsors

Lead Sponsor: Universität Duisburg-Essen

Source Universität Duisburg-Essen
Brief Summary

Despite the long tradition of complementary and alternative medicine (CAM) therapies there are hardly any interventional trials on type 2 diabetes mellitus. Hence this pilot study aims to investigate the influence of a two weeks integrative inpatient therapy on the quality of life in 50 patients suffering from diabetic neuropathy. Integrative treatment includes aspects of conventional and traditional European and Chinese medicine, mind-body medicine, physical therapy and lifestyle modification (nutrition advices, stress management and exercise training). The observational design intends four measurement points: tree months before (T0), directly before (T1), directly after treatment (T2) and three months follow-up (T3). The subjective evaluation of the neuropathy-related quality of life was combined with neurophysiologic instruments (QST), to measure neuropathic symptoms. Also pain intensity, locus of control, interpretation of illness, coping style, anxiety/depression, life satisfaction and several biomarkers (HbA1c, ABI, WHR and BMI) are measured. In addition a qualitative interview should give a view to patient perspective of therapy process.

Overall Status Completed
Start Date March 2011
Completion Date July 2012
Primary Completion Date July 2012
Study Type Observational
Primary Outcome
Measure Time Frame
Neuropathy-related Quality of Life (QOL-DN) at T2
Neuropathy-related Quality of Life (QOL-DN) at T3
Secondary Outcome
Measure Time Frame
Quantitative Sensory Testing (QST) at T2 and T3
Pain intensity (VAS) at T2 and T3
Control Beliefs (MHLC / short form) at T2 and T3
Interpretation of Illness (IIQ) at T2 and T3
Coping Style (AKU) at T2 and T3
Anxiety and Depression (HADS) at T2 and T3
Life Satisfaction (SWLS) at T2 and T3
Blood sugar Level (HbA1c) at T2 and T3
Waist-to-Hip Ratio (WHR) and Body Mass Index (BMI) at T2 and T3
Enrollment 6
Condition
Intervention

Intervention Type: Other

Intervention Name: inpatient integrative treatment

Description: two weeks inpatient integrative therapy: conventional medicine, traditional European and Chinese medicine (TCM), mind-body medicine, physical therapy, lifestyle modification program: nutrition advices, stress management, exercise training

Arm Group Label: type 2 diabetics with neuropathy

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- over 18 years old

- diabetes mellitus type 2

Exclusion Criteria:

- diabetes mellitus type 1

- pregnancy

- oncologic diseases

- systemic neurological diseases

- other induced neuropathy (radicular, s/p alcohol abuse, chemotherapy-induced)

- other severe psychiatric or somatic comorbidity

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Gustav J. Dobos, Prof. MD Principal Investigator University of Duisburg-Essen
Location
Facility: Kliniken Essen-Mitte
Location Countries

Germany

Verification Date

July 2012

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Universität Duisburg-Essen

Investigator Full Name: Heidemarie Haller

Investigator Title: MSc

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: type 2 diabetics with neuropathy

Acronym CIT-DN
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov